FDA Warning Letters, 483s and Recalls: July 2024

FDA enforcement records dated July 2024: 45 warning letters outside tobacco (plus 16 tobacco letters), 37 OAI inspections and 87 Class I recalls. FDA publishes some records weeks after their date, so recent months can still grow.

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Warning letters

A warning letter is FDA's formal notice that a firm has significant violations. Company names link to the letter on fda.gov. Tobacco retailer letters are counted above but not listed.

DateCompanyIssuing officeSubject
Jul 31, 2024BullyKamp Products LLCCenter for Veterinary MedicineUnapproved New Animal Drug Products
Jul 31, 2024P&L Bean Sprout FarmDivision of Human and Animal Food Operations East IIFood/Prepared Packed or Held Under Insanitary Conditions/Adulterated
Jul 31, 2024Top Dog Pet Store LLC Dba The Bulldog CartelCenter for Veterinary MedicineUnapproved New Animal Drug Products
Jul 29, 20241 Stop Chicken Health ShopCenter for Veterinary MedicineUnapproved New Animal Drug Products
Jul 26, 2024CARsgen Therapeutics CorporationCenter for Biologics Evaluation and ResearchCGMP/Finished Pharmaceuticals/Adulterated
Jul 25, 2024Amazon.Com, Inc.Center for Drug Evaluation and Research (CDER)Finished Pharmaceuticals/Unapproved New Drugs
Jul 25, 2024ISIS.GOLDCenter for Drug Evaluation and Research (CDER)Finished Pharmaceuticals/Unapproved New Drugs
Jul 25, 2024Matte BeautyCenter for Drug Evaluation and Research (CDER)Finished Pharmaceuticals/Unapproved New Drugs
Jul 25, 2024Repare SkincareCenter for Drug Evaluation and Research (CDER)Finished Pharmaceuticals/Unapproved New Drugs
Jul 25, 2024Skin Beauty SolutionsCenter for Drug Evaluation and Research (CDER)Finished Pharmaceuticals/Unapproved New Drugs
Jul 25, 2024Walmart, Inc.Center for Drug Evaluation and Research (CDER)Finished Pharmaceuticals/Unapproved New Drugs
Jul 24, 2024Aerosol And Liquid Packaging, Inc.Division of Pharmaceutical Quality Operations ICGMP/Finished Pharmaceuticals/Adulterated
Jul 24, 2024Corporacion Avicola Morovis IncOffice of Regulatory AffairsPHS Act/Shell Egg Regulation/Adulterated
Jul 24, 2024Txsyn Int. LLCDivision of Human and Animal Food Operations West IIICGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Jul 24, 2024Warbucks Seafood NY LLCDivision of Northeast ImportsForeign Supplier Verification Program (FSVP)
Jul 23, 2024Minland Of Texas, Inc.Division of Southwest ImportsForeign Supplier Verification Program (FSVP)
Jul 23, 2024Omega Tech Labs LLCDivision of Pharmaceutical Quality Operations IVCGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
Jul 22, 2024V10Suppliers.ComCenter for Drug Evaluation and Research (CDER)Finished Pharmaceuticals/Unapproved New Drug/Misbranded
Jul 18, 2024Jiangsu Caina Medical Co., LtdCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Jul 18, 2024Jiangsu Shenli Medical Production Co., Ltd.Center for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Jul 17, 2024TJA Health, LLCDivision of Pharmaceutical Quality Operations IIICGMP/Finished Pharmaceuticals/Adulterated
Jul 17, 2024Velocity Pharma LLCCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Jul 16, 2024La Parcela Produce LLCDivision of Northern Border ImportsForeign Supplier Verification Program (FSVP)
Jul 15, 2024Earthly HempsCenter for Food Safety and Applied Nutrition (CFSAN)Interstate Commerce/Food/Adulterated/Unfair or Deceptive Marketing
Jul 15, 2024Globus Medical, Inc.Office of Medical Device and Radiological Health Division ICGMP/QSR/Drug/Medical Devices/Adulterated
Jul 15, 2024Grow God, LLCCenter for Food Safety and Applied Nutrition (CFSAN)Interstate Commerce/Food/Adulterated/Unfair or Deceptive Marketing
Jul 15, 2024Hippy MoodCenter for Food Safety and Applied Nutrition (CFSAN)Interstate Commerce/Food/Adulterated/Unfair or Deceptive Marketing
Jul 15, 2024Life Leaf Medical CBD CenterCenter for Food Safety and Applied Nutrition (CFSAN)Interstate Commerce/Food/Adulterated/Unfair or Deceptive Marketing
Jul 15, 2024Mary Jane's Bakery Co. LLCCenter for Food Safety and Applied Nutrition (CFSAN)Interstate Commerce/Food/Adulterated/Unfair or Deceptive Marketing
Jul 15, 2024Shamrockshrooms.ComCenter for Food Safety and Applied Nutrition (CFSAN)Interstate Commerce/Food/Adulterated/Unfair or Deceptive Marketing
Jul 12, 2024Criticare Technologies, Inc.Division of Medical Device and Radiological Health Operations EastCGMP/QSR/Medical Devices/Adulterated
Jul 12, 2024EyePoint Pharmaceuticals, Inc.Office of Pharmaceutical Quality Operations Division ICGMP/Drugs/Adulterated
Jul 11, 2024Brassica Pharma Pvt. Ltd.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Jul 11, 2024Green Day Produce, Inc.Division of West Coast ImportsForeign Supplier Verification Program (FSVP)
Jul 11, 2024Jiangsu Hengrui Pharmaceuticals Co., Ltd.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Jul 11, 2024Nowrez & Ismail Shukri CompanyCenter for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Jul 11, 2024White Label Leaf, LLC/Flying Monkey US, LLCCenter for Food Safety and Applied Nutrition (CFSAN)Adulterated Human Foods/Unapproved New Drugs
Jul 10, 2024Central Admixture Pharmacy Services, Inc.Division of Pharmaceutical Quality Operations IVCompounding Pharmacy/Adulterated Drug Products
Jul 9, 2024Cholrem Pty Ltd Dba Cholrem And Cholrem PharmaceuticalsCenter for Drug Evaluation and Research (CDER)Finished Pharmaceuticals/Unapproved New Drugs
Jul 9, 2024Formulation Technology, Inc.Division of Human and Animal Food Operations West VNew Drugs/Dietary Supplements/Food Labeling/Misbranded
Jul 8, 2024Greenfruit Avocados, LLCDivision of West Coast ImportsForeign Supplier Verification Program (FSVP)
Jul 8, 2024High Quality Organics, Inc.Division of Human and Animal Food Operations West VCGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Jul 8, 2024YangZhou SuXiang Medical Instrument Co., Ltd.Center for Drug Evaluation and Research (CDER)CGMP/Finished Pharmaceuticals/Adulterated
Jul 2, 2024Premier Manufacturing Products, LLCCenter for Drug Evaluation and Research | CDERFinished Pharmaceuticals/Unapproved New Drug
Jul 1, 2024Genuine Virgin Aloe Corp Dba TridermaDivision of Pharmaceutical Quality Operations IVCGMP/Finished Pharmaceuticals/Adulterated

OAI inspections

OAI (Official Action Indicated) means FDA recommends regulatory and/or administrative action after the inspection. Facility names link to the facility's FDA record.

DateFacilityProduct typeCountry
Jul 31, 2024Argon Medical Productions & Vertrieb Gesellschaft MBH & CODevicesGermany
Jul 29, 2024Denison Pharmaceuticals, LLCDrugsUnited States
Jul 26, 2024Bhargava Phytolab Private LimitedDrugsIndia
Jul 26, 2024Nubratori, IncDrugsUnited States
Jul 26, 2024Qilu Animal Health Products Co., Ltd.VeterinaryChina
Jul 26, 2024Red Oak Instruments, LLCDevicesUnited States
Jul 26, 2024Shenzhen Fitfaith Technology Co., Ltd.DevicesChina
Jul 26, 2024Sombra Cosmetics, IncDrugsUnited States
Jul 26, 2024WINFULL CORPORATIONFood/CosmeticsUnited States
Jul 25, 2024Agila CorporationVeterinaryUnited States
Jul 25, 2024Boka Imports LLCFood/CosmeticsUnited States
Jul 25, 2024NAVISWISS AGDevicesSwitzerland
Jul 25, 2024Rontis Hellas S.A.DevicesGreece
Jul 25, 2024SSP America PHX, LLCFood/CosmeticsUnited States
Jul 22, 2024OL Pharma Tech LLCDrugsUnited States
Jul 19, 2024Atlanta Supersource, Inc.DrugsUnited States
Jul 18, 2024Consolidated Trading, Inc.TobaccoUnited States
Jul 17, 2024GLOBAL SOURCE DISTRIBUTION, SCorp.TobaccoUnited States
Jul 17, 2024PSD Partners, LLCVeterinaryUnited States
Jul 17, 2024Revolution Foods, PBCFood/CosmeticsUnited States
Jul 16, 2024Ocho Rios-Miami, Inc.Food/CosmeticsUnited States
Jul 15, 2024Avlon Industries, IncDrugsUnited States
Jul 12, 2024Verdure Sciences, Inc.DrugsUnited States
Jul 11, 2024Future Diagnostics Solutions B.V.DevicesNetherlands
Jul 11, 2024Maquet Cardiovascular, LLCDevicesUnited States
Jul 11, 2024Master Sales LLCTobaccoUnited States
Jul 11, 2024Rolence Ent. Inc.DevicesTaiwan
Jul 11, 2024Salt City Baking Company, LLCFood/CosmeticsUnited States
Jul 11, 2024Southeast Distro Inc.TobaccoUnited States
Jul 11, 2024TAMPON INNOVATIONSDevicesBulgaria
Jul 9, 2024Duong Ha Processing Trading Seafood Company LimitedFood/CosmeticsVietnam
Jul 9, 2024Genzyme CorporationDrugsUnited States
Jul 5, 2024FUTURE BEST TRADING INCFood/CosmeticsUnited States
Jul 3, 2024BSO LLCDrugsUnited States
Jul 3, 2024Health Pharma USA LLCDrugsUnited States
Jul 2, 2024US Specialty Formulations LLCDrugsUnited States
Jul 1, 2024Anglo Freight USA Inc.Food/CosmeticsUnited States

Most-cited Form 483 sections

The CFR sections FDA investigators cited most often in inspections that ended this month.

CFR sectionObservationCitations
21 CFR 1.502(a)Develop FSVP28
21 CFR 117.35(a)Sanitary operations - Plant sanitation25
21 CFR 820.100(a)Lack of or inadequate procedures20
21 CFR 820.198(a)Lack of or inadequate complaint procedures18
21 CFR 117.35(c)Pest control16
21 CFR 211.22(d)Procedures not in writing, fully followed16
21 CFR 117.10Personnel14
21 CFR 117.135(a)(1)Sanitation preventive controls - Implement14
21 CFR 820.30(g)Design validation - user needs and intended uses13
21 CFR 117.80(c)Manufacturing, processing, packing, holding - Controls11

Class I recalls

Class I is FDA's most serious recall class: a reasonable chance the product causes serious health problems or death.

DateFirmProduct typeReason
Jul 31, 2024Medtronic MiniMed, Inc.DevicesInsulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may…
Jul 31, 2024Medtronic MiniMed, Inc.DevicesInsulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may…
Jul 31, 2024Medtronic MiniMed, Inc.DevicesInsulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may…
Jul 31, 2024Metro Produce Distributors, Inc.FoodGuacamole products may be contaminated with Listeria monocytogenes.
Jul 31, 2024Metro Produce Distributors, Inc.FoodGuacamole products may be contaminated with Listeria monocytogenes.
Jul 31, 2024Metro Produce Distributors, Inc.FoodGuacamole products may be contaminated with Listeria monocytogenes.
Jul 31, 2024Metro Produce Distributors, Inc.FoodGuacamole products may be contaminated with Listeria monocytogenes.
Jul 31, 2024Metro Produce Distributors, Inc.FoodGuacamole products may be contaminated with Listeria monocytogenes.
Jul 30, 2024Publix Super Markets, Inc.FoodPotential Listeria Monocytogenes
Jul 29, 2024Van Leeuwen Ice Cream LLCFoodUndeclared peanuts (allergen)
Jul 25, 2024Breas Medical, Inc.DevicesThere is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in…
Jul 24, 2024Abbott Diabetes Care, Inc.DevicesUsers of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously high glucose results. The inaccurate…
Jul 24, 2024B. Braun Medical IncDrugsPresence of Particulate Matter
Jul 19, 2024GBC Food Services, LLC Dba Yummi SushiFoodpossible contamination with Listeria Monocytogenes.
Jul 19, 2024GBC Food Services, LLC Dba Yummi SushiFoodpossible contamination with Listeria Monocytogenes.
Jul 19, 2024GBC Food Services, LLC Dba Yummi SushiFoodpossible contamination with Listeria Monocytogenes.
Jul 19, 2024Inari Medical - Oak CanyonDevicesThrombectomy system catheter instructions for use updated to reduce adverse events due to the following circumstances: 1) Fibrous, firmly…
Jul 19, 2024JFE FRANCHISING INCFoodListeria monocytogenes
Jul 19, 2024JFE FRANCHISING INCFoodListeria monocytogenes
Jul 19, 2024JFE FRANCHISING INCFoodListeria monocytogenes
Jul 19, 2024JFE FRANCHISING INCFoodListeria monocytogenes
Jul 19, 2024JFE FRANCHISING INCFoodListeria monocytogenes
Jul 19, 2024JFE FRANCHISING INCFoodListeria monocytogenes
Jul 19, 2024RS Hanline And Company IncFoodPotential contamination with Listeria monocyotgenes
Jul 19, 2024RS Hanline And Company IncFoodPotential contamination with Listeria monocyotgenes
Jul 19, 2024RS Hanline And Company IncFoodPotential contamination with Listeria monocyotgenes
Jul 19, 2024RS Hanline And Company IncFoodPotential contamination with Listeria monocyotgenes
Jul 19, 2024RS Hanline And Company IncFoodPotential contamination with Listeria monocyotgenes
Jul 19, 2024RS Hanline And Company IncFoodPotential contamination with Listeria monocyotgenes
Jul 18, 2024MAIN PRODUCTS INCDrugsMarketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Jul 17, 2024Kenny's Farmhouse CheeseFoodPotential contamination with Listeria monocytogenes
Jul 16, 2024Philips Respironics, Inc.DevicesFirm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve…
Jul 16, 2024Philips Respironics, Inc.DevicesFirm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve…
Jul 16, 2024Philips Respironics, Inc.DevicesFirm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve…
Jul 16, 2024Smiths Medical ASD Inc.DevicesDamage to the battery pack may have caused a short to a capacitor within the battery pack. While the battery encasement is designed to be…
Jul 12, 2024Datex-Ohmeda, Inc.DevicesPotential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet…
Jul 12, 2024Datex-Ohmeda, Inc.DevicesPotential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO)…
Jul 12, 2024Datex-Ohmeda, Inc.DevicesPotential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet…
Jul 12, 2024Datex-Ohmeda, Inc.DevicesPotential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet…
Jul 12, 2024Datex-Ohmeda, Inc.DevicesPotential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet…
Jul 12, 2024Datex-Ohmeda, Inc.DevicesPotential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet…
Jul 12, 2024Datex-Ohmeda, Inc.DevicesPotential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet…
Jul 12, 2024Datex-Ohmeda, Inc.DevicesPotential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet…
Jul 12, 2024Datex-Ohmeda, Inc.DevicesPotential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet…
Jul 12, 2024Datex-Ohmeda, Inc.DevicesPotential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO)…
Jul 12, 2024Datex-Ohmeda, Inc.DevicesPotential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet…
Jul 12, 2024Defibtech, LLCDevicesProblem in the device's motor may cause the device to stop compressions. This may lead to a delay in therapy if the device fails to…
Jul 12, 2024SoloVitalDrugsMarketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Jul 12, 2024Supercore Products Group Inc.DrugsMarketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Jul 12, 2024Supercore Products Group Inc.DrugsMarketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Jul 11, 2024AB WORLD FOODS US INCFoodPotential to be contaminated with Salmonella
Jul 11, 2024Aurobindo Pharma USA IncDrugsLabeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Jul 11, 2024Bazzini LLCFoodUndeclared peanuts
Jul 11, 2024Wiers Farm IncFoodListeria monocyotgenes contamination
Jul 11, 2024Wiers Farm IncFoodListeria monocyotgenes contamination
Jul 11, 2024Wiers Farm IncFoodListeria monocyotgenes contamination
Jul 11, 2024Wiers Farm IncFoodListeria monocyotgenes contamination
Jul 11, 2024Wiers Farm IncFoodListeria monocyotgenes contamination
Jul 11, 2024Wiers Farm IncFoodListeria monocyotgenes contamination
Jul 11, 2024Wiers Farm IncFoodListeria monocyotgenes contamination
Jul 11, 2024Wiers Farm IncFoodListeria monocyotgenes contamination
Jul 11, 2024Wiers Farm IncFoodListeria monocyotgenes contamination
Jul 11, 2024Wiers Farm IncFoodListeria monocyotgenes contamination
Jul 11, 2024Wiers Farm IncFoodListeria monocyotgenes contamination
Jul 11, 2024Wiers Farm IncFoodListeria monocyotgenes contamination
Jul 11, 2024Wiers Farm IncFoodListeria monocyotgenes contamination
Jul 11, 2024Wiers Farm IncFoodListeria monocyotgenes contamination
Jul 11, 2024Wiers Farm IncFoodListeria monocyotgenes contamination
Jul 11, 2024Wiers Farm IncFoodListeria monocyotgenes contamination
Jul 11, 2024Wiers Farm IncFoodListeria monocyotgenes contamination
Jul 11, 2024Wiers Farm IncFoodListeria monocyotgenes contamination
Jul 11, 2024Wiers Farm IncFoodListeria monocyotgenes contamination
Jul 11, 2024Wiers Farm IncFoodListeria monocyotgenes contamination
Jul 11, 2024Wiers Farm IncFoodListeria monocyotgenes contamination
Jul 11, 2024Wiers Farm IncFoodListeria monocyotgenes contamination
Jul 11, 2024Wiers Farm IncFoodListeria monocyotgenes contamination
Jul 11, 2024Wiers Farm IncFoodListeria monocyotgenes contamination
Jul 11, 2024Wiers Farm IncFoodListeria monocyotgenes contamination
Jul 11, 2024Wiers Farm IncFoodListeria monocyotgenes contamination
Jul 11, 2024Wiers Farm IncFoodListeria monocyotgenes contamination
Jul 10, 2024Endo Pharmaceuticals, Inc.DrugsLabeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside…
Jul 9, 2024CovidienDevicesBattery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by…
Jul 9, 2024CovidienDevicesBattery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by…
Jul 8, 2024Hikma Pharmaceuticals USA Inc.DrugsLabeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen…
Jul 8, 2024Stutz Packing CompanyFoodShelled walnuts tested positive for Listeria
Jul 3, 2024Costco Wholesale CorporationFoodUndeclared Almond and Soy. The Grain + Celery Salad with Apple Cider Vinaigrette item #47492 was inadvertently mis-labeled as Ancient…
Jul 1, 2024Leona'sFoodThe product has cross contamination with peanuts.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.